AUTH/3455/1/21 - Complainant v Sanofi

Promotion of Toujeo Double Star (insulin glargine)

  • Received
    20 January 2021
  • Case number
  • Applicable Code year
  • Completed
    19 August 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable complainant complained about the conduct of a Sanofi representative at a virtual meeting to promote Toujeo (insulin glargine solution (300 units/ml) for injection in a pre-filled pen).
Toujeo was indicated for the treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Toujeo was available in two pen sizes: a SoloStar pen (contained 1.5 ml of solution for injection, equivalent to 450 units) and a DoubleStar pen (contained 3 ml of solution for injection, equivalent to 900 units).
The complainant alleged that the representative claimed that using DoubleStar resulted in fewer prescriptions and when he/she queried why that was the case and suggested that it was erroneous and misleading, the representative simply moved on. There was also a suggestion that fewer prescriptions would result in a time and cost saving. The complainant stated that he/she repeatedly pointed out that the claim was incorrect (fewer pens, not fewer prescriptions), but this was not acknowledged.

The representative went on to discuss a health professional programme within the same presentation which the complainant alleged was inappropriate. The programme was discussed to further promote Toujeo ie by using Toujeo health professionals would be invited to a remote insulin management meeting. A copy of a slide which appeared to refer to a programme named PRIME (providing remote insulin management & education) was provided.

The detailed response from Sanofi is given below.

The Panel noted Sanofi’s submission that it had been discussed internally and decided that the claim ‘fewer prescriptions’ in relation to the use of the Toujeo DoubleStar pen within the Toujeo promotional slide deck (ref MAT-GB-2004667 (V1.0)) could not be substantiated. In error, the slide deck including the claim at issue was approved on 13 November 2020. The Panel noted Sanofi’s submission that the error was identified and flagged internally on 25 November 2020 and a revised slide deck was issued on 4 December 2020 to replace the inaccurate version.

The Panel considered that the claim that Toujeo DoubleStar offered ‘fewer prescriptions’ in the presentation certified on 13 November and available until 4 December 2020 was misleading and incapable of substantiation and high standards had not been maintained; breaches of the Code were ruled as acknowledged by Sanofi.

The Panel noted Sanofi’s submission that whilst the briefing for representatives stated the intended audience and an overview of what was going to be covered in the slide deck, it did not contain any guidance on how to discuss the claim of ‘fewer prescriptions’ because it was not intended to be included in the slide deck. The Panel further noted Sanofi’s submission that, overall, briefing for this slide deck should have been more detailed and matched the associated material. The Panel did not consider that the briefing was sufficiently detailed and a breach of the Code was ruled as acknowledged by Sanofi.

In relation to the allegation that a health professional programme (PRIME) had been inappropriately discussed in the presentation, implying that if Toujeo was used those health professionals would be invited to a remote insulin management meeting, the Panel noted Sanofi’s submission that PRIME (Providing Remote Insulin Management and Education) was a promotional educational programme intended for all health professionals (regardless of their prescribing habits) involved in treating patients with insulin, to help them better manage their patients remotely in the current climate [pandemic].

The Panel noted that, according to the briefing (ref MAT-GB-2004668 (V1.0)) in relation to the Toujeo promotional speaker slide kit (ref MAT-GB-2004667 (V1.0)), the slide kit was only to be used if it met one or both of the following scenarios: following a recent clinical presentation on Toujeo (within 1 month) and/or where the audience included health professionals who were known prescribers of Toujeo and were aware of the clinical data for Toujeo.

The Panel, however, noted Sanofi’s submission that only one slide out of fifteen, in the Toujeo promotional speaker slide kit, included a brief summary of the PRIME programme as an example of how Sanofi was trying to support its customers during the pandemic and that the content of that slide, along with the briefing for the entire deck, contained no language suggestive of any intent to link the offering with prescribing of any Sanofi product, including Toujeo. The slide described PRIME as a learning programme intended for primary and intermediate care health professionals to effectively and confidently manage patients on insulin remotely. The Panel further noted Sanofi’s submission that it interviewed a selection of members of the diabetes sales force and did not find any evidence that PRIME was discussed in any way as an inducement to prescribe a Sanofi medicine and no concerns had been raised to representatives in any meetings.

The Panel noted that the materials and associated content for the PRIME programme were not before it and were not the subject of the complaint. The Panel did not consider that the complainant had provided evidence to establish that the slide summarising the PRIME programme, as part of a promotional presentation, was inappropriate, as alleged, such that it was an inducement to prescribe, supply, administer, recommend, buy or sell any medicine; no breaches of the Code were ruled including Clause 2.